Senior Scientist – IVD Assay Development
This senior-level scientific role sits within the R&D division of a global healthcare leader’s high-growth Infectious Disease business unit. The position acts as an independent contributor and lead scientist, driving the design, development, and optimization of novel in vitro diagnostic (IVD) assays from conception to commercialization.

Key Responsibilities

• Assay Design & Optimization: Conceive, plan, and execute advanced studies to develop and optimize novel serological and molecular diagnostic tests (including lateral flow devices).
• Technical Leadership: Provide cross-site scientific direction, study design guidance, and mentorship/coaching to junior scientists within the R&D organization.
• Cross-Functional Support: Partner closely with Quality, Manufacturing, and Regulatory teams to support external regulatory audits, certification activities, and audit responses.
• Strategic Decision Making: Make high-level technical decisions regarding project priorities while maintaining alignment and buy-in from cross-functional leadership.
• Compliance & QMS: Create and maintain development standards, training programs, and standard operating procedures (SOPs) to ensure all R&D activities strictly comply with the established Quality Management System.
• External Collaboration: Build and manage strategic relationships with third-level academic institutions, contract testing labs, key suppliers, and consulting partners.

• Experience: 10+ years of essential experience in in vitro diagnostics (IVD), assay development, and biologics within a regulated environment.
• Technical Expertise: Strong molecular biology and biochemistry background with proven expertise in protein expression, protein chemistry, and serological diagnostic test design.
• Data & Analytics: Advanced quantitative skills, including proficiency in statistical analysis and Design of Experiments (DOE) optimization.
• Adaptability: Proven track record of navigating a dynamic, fast-paced commercial environment and troubleshooting complex technical issues independently.